Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands An agency of the European Union Address for visits and deliveries Refer to www ema europa eu/how to find us Send us a qu[.]
05 September 2022 EMA/444925/2018 IRIS guide for applicants (How to create and submit scientific applications, for industry and individual applicants) Version 2.12 Table of Contents Revision History Table of abbreviations Purpose and context 1.1 Purpose of this guide 1.2 Preliminary requirement 1.3 Supported Browsers Common operations for all scientific submission types 2.1 Display and sort submissions 2.2 Search for submissions 2.3 Create a new submission (general procedure for all submission types) 2.4 Communication only to the Submission Contact (Portal contact) for a submission 2.5 Add managers to a draft/ongoing submission 2.6 Add contributors to a draft submission 10 2.7 Delete a draft submission 10 2.8 Withdrawal of a Submission 10 2.9 Automatic deletion of draft submissions 11 2.10 Respond to a notification email from EMA requesting changes 11 2.11 Respond to a List of Questions (LoQ) request 12 2.12 Check the current status of an ongoing Submission in the IRIS Portal 12 2.13 Regulatory Entitlements Affiliation 13 2.13.1 Regulatory Entitlements 13 2.13.2 My Individual Regulatory Entitlements 13 2.14 Products - Research Product Identifiers (RPI) 14 Official address Domenico Scarlattilaan ● 1083 HS Amsterdam ● The Netherlands Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us Send us a question Go to www.ema.europa.eu/contact An agency of the European Union Telephone +31 (0)88 781 6000 © European Medicines Agency, 2022 Reproduction is authorised provided the source is acknowledged Orphan submissions 15 3.1 Create an application for orphan designation 15 3.2 Request a Pre-Submission Meeting (for OD) 15 Request an Appeal (of a COMP Opinion) 16 3.3 Submit an Annual Report for an orphan designation 16 3.4 Other post-designation procedures for orphan-designated products 17 3.5 How to check if an Orphan Drug Sponsor (Location of an organisation) has associated Regulatory entitlements 17 Scientific Advice 17 4.1 Create an application for an Initial Scientific Advice (Human) 17 4.2 Create an application for other Scientific Advice procedures 18 4.2.1 Initial Scientific Advice – Veterinary 18 4.2.2 Initial Protocol Assistance 19 4.2.3 Initial Qualification Procedure 19 4.2.4 Follow up Scientific Advice – Human 19 4.2.5 Follow up Scientific Advice – Veterinary 19 4.2.6 Follow up Protocol Assistance 20 4.2.7 Follow up Qualification Procedure 20 4.2.8 Transfer a Scientific Advice 20 4.2.9 Clarification on Scientific Advice 21 4.2.10 Scientific Advice FAQ 22 ITF Briefing Meeting Requests 22 Marketing Status 23 6.1 Marketing Status Notification (Single) 24 6.2 Marketing Status Notification (Bulk Upload) 27 6.3 Marketing Status Withdrawal Notification 31 6.4 Marketing Status Report 33 Inspections 35 7.1 GMP inspections 35 7.2 GCP Inspections 38 7.3 GVP Inspections 41 Veterinary Signal Management 42 8.1 Annual statements submission 43 8.2 Signal management submission 43 Registration of an MAH i-SPOC on supply and availability 45 9.1 Purpose of this section 45 9.2 Preliminary requirement as defined in step 45 9.3 Supported Browsers 45 9.4 Background 46 9.5 Registering an MAH i-SPOC as defined in step 46 9.6 Update an MAH i-SPOC 52 9.7 Maintain the same i-SPOC for multiple local affiliates 54 Revision History Date Description 27/06/22 Added Section Registration of an MAH i-SPOC on supply and availability 05/09/22 Section Inspections updated Table of abbreviations Abbrevi ation Explanation CAP Centrally Authorised Product CHMP Committee for Human Medicinal Products COMP Committee for Orphan Medicinal Products CVMP Committee for Veterinary Medicinal Products EC European Commission EMA European Medicines Agency ESMP European Shortages Monitoring platform ETF Emergency Task Force EU European Union GCP Good Clinical Practice GMP Good Manufacturing Practice IAM Identity & Access Management ITF Innovation Task Force LoQ List of Questions MS Member State MSSG Medicine Shortages Steering Group OD Orphan Designation OMS Organisation Management Service (part of SPOR) PD Parallel Distribution RPI Research Product Identifier SA Scientific Advice SPOR Management Services for Substances, Products, Organisations and Referential Terms Purpose and context 1.1 Purpose of this guide This guide has been produced to show applicants how to use the IRIS platform to prepare and submit an application and/or data for a scientific procedure (orphan designation application, scientific advice, ITF briefing meeting requests, marketing status reports, inspections and veterinary signal management) and related activities For Parallel Distribution procedures separate user access roles are needed and separate guidance is available on the IRIS home page 1.2 Preliminary requirement EMA Account and appropriate role: for any type of submission in IRIS, you need an EMA account and an appropriate role in IRIS, to login into IRIS Registration needs to be done only once and will allow you to submit any type of scientific applications now and in the future For information on how to request an EMA account and an appropriate IRIS role (these are two separate actions), please consult the separate IRIS guide to registration and the quick interactive guide to IRIS registration process on the IRIS home page This guide also contains information on how to request or transfer an RPI (Research Product Identifier) 1.3 Supported Browsers IRIS can be accessed on any modern Web Browser, including but not limited to Google Chrome (latest version), Internet Explorer 11 and above, Edge (including the new, Chromium-based Edge), Safari 12 and above, Firefox (latest version), Vivaldi, etc Common operations for all scientific submission types 2.1 Display and sort submissions From the IRIS home page, after sign-in, click on any of the options: “Draft Submissions”, “Ongoing Submissions” or “Completed Submissions” present under “Submissions” Tab; If you have an IRIS Industry Manager role, you will see all the submissions that you have created, plus all the submissions in which you have been added as a contributor If you have a Contributor role, you will see all the Submissions to which you have been added as a Contributor If you have both roles, you will see all submissions of your own and those for which you have been added as a Contributor In all cases, you will see submissions for all the Organisations to which you are affiliated (in IAM); Click on any of the column headings that appear in blue font, and the rows listed in the table will be sorted in ascending order (click again for descending order) 2.2 Search for submissions You can obtain a restricted subset of your submissions: from the IRIS home page, select first “Draft Submissions”, “Ongoing Submissions” or “Completed Submissions”; In the search bar, enter any string (combination of letters and/or numbers) that will identify the submission you are looking for and might be contained in the columns that are displayed on screen (e.g "Submission ID", "Organisation", "Submission Type"); by including an asterisk (*) as first character, the search string will apply to text in any position; Click on the magnifying glass search symbol or press "Enter" on your keyboard to launch the search; A list of the relevant results that match the search criterion you typed in the search bar will be displayed The list can be sorted as described in the previous section; In “Draft submissions”, a menu of different actions can be elicited by clicking on the down arrow to the right of the relevant submission You can edit or delete the submission, manage the contributors and managers, and change the “submission contact” (the person who will receive by default all the email communications for the procedure) (see Figure 1) Figure 1: Managing draft submissions 2.3 Create a new submission (general procedure for all submission types) From the IRIS home page, click on “Draft submissions” sub-tab present under “Submission” tab; Click “Create new submission” [a screen with the heading “Portal – New Submissions” opens showing stages The first stage “1 Choose Applicant Type” is highlighted in blue]; From the drop-down arrow on the box below “Are you applying as an individual or on behalf of an organisation?” select the appropriate answer and click “Next”; Only if you are applying on behalf of an organisation: Use the magnifying glass search symbol to look up the organisations available for you to select (N.B only the organisation(s) affiliated to the portal user role that you logged into the portal as will be displayed here); Pick the right organisation and (there may only be one) and click “Select”; Use the search symbol to look up the locations available for you to select, pick the right one and click “Select”; please note that the Regulatory entitlement (Orphan Designation) will be granted to the address of this location and the relevant organisation; NOTE: it is strongly recommended to use only one location (normally the legal seat of the organisation) for all IRIS submissions, RPIs and regulatory entitlements This simplifies your management of submissions in IRIS “Choose Submission Type” is now coloured blue and mandatory fields (marked with a red asterisk “*”) appear labelled “Organisation” “Location” and “Submission Type” (the first two only if you are applying on behalf of an organisation) Use the search symbol to look up the submission types available, click on the appropriate submission type and then on “Select”; Add at least one Manager in the specific field (when applying on behalf of an organisation, the pop-up list will only include those people who have been granted an IRIS Industry Manager access role that is affiliated to the specific organisation (Company + Country) you selected in the previous screen If no-one has done this, the list will be empty) It is strongly recommended to have at least two Managers (preferably three) for each IRIS submission: this will allow the applicant continued access to the submission even if one the managers leaves the company or is absent for prolonged periods; Click “Create and Next” A new screen appears with a reference number (e.g EMA/XX/0000001234) for your draft submission displayed on the upper right-hand side of the “Portal – New Submission” screen (N.B It is a good idea to take note of the reference number created) There is also now a list of various tabs (steps) including “Select RPI” and ending with “Declaration”) relating to the submission reference displayed on the left-hand side of your screen (see Figure 2) Figure 2: Example of new submission Click on “Select RPI” to bring up “Research Product Identifier (RPI)” screen: Click the magnifying glass search symbol to bring up a list of RPI names; In the pop-up window, pick an RPI name from the list and click “Select”; Back in the “Research Product Identifier (RPI)” screen, click “Save and Return” and you are returned to the “Submission Form” screen; If you not see the RPI for your product in the list: An RPI tracks the development of a medicinal product The RPI remains the same when the name of the substance(s) in the product changes, or when development of the product is transferred to a different product If you have already submitted an application to EMA for your product, it is very likely that an RPI already exists, and that one should be used RPIs are assigned to an OMS Location (specific address), not to a parent organisation Consequently when creating a submission in the name of a specific location, only those RPIs assigned to that location can be chosen It is therefore recommended that all RPIs (and regulatory entitlement) for an organisation are assigned to the same location (normally the legal seat of the organisation) The RPI may already exist, but “owned” by another sister company in the same or a different country, a different company or a consultant, or it may be assigned to a different location of your organisation In such cases, it won’t appear in the selection list, and you need either to request affiliation to the RPI “owner”, or the “owner” should transfer the RPI to your company, depending on which company should be the sponsor of the orphan designation To transfer an RPI reference the IRIS guide to registration section 8.3 “Transfer a Research Product Identifier (RPI)” If you are sure that no RPI exists for the medicinal product yet, please request one via IRIS following IRIS guide to registration section 8.2 “How to request a new RPI” This is a separate submission After receiving communication from EMA that your RPI has been created, you can go back to your draft submission and proceed to the steps below If your RPI is intended to cover multiple products or a methodology/ technology or a method or other (not a single product), please contact ITFSecretariat@ema.europa.eu or ScientificAdvice@ema.europa.eu If you plan to submit SA or Qualification request you will be requested to complete a specific Word form and an RPI will be crated and provided you If you apply for ITF BM most of the information is already available for ITF Secretariat in the initial request form and an RPI will be created and provided to you These ‘special’ RPIs cannot be requested by you via IRIS Click on “Additional product information/update”: Make sure that the list of innovation/enabling technologies includes at least one term; if not, choose at least one with the “Add” button; Click “Save and return” Once the RPI data (and any other mandatory sections) are completed, all the sections (tabs) will turn from grey to blue and will be active (see Figure 2) Fill in each section Please note that fields with a red asterisk are mandatory You need to complete each section before you can save it, but it is not mandatory to fill in all the section in one session; Back in the main “Submission Form” Screen, click on “Documents from Applicant”: In the next screen that appears, you can directly upload documents to your submission While there is no maximum number of files or global size, there is a size limit of 50 Mb per file Please upload individual files for each document, rather than a single Zip file (or similar) for the set of all documents; it is possible to upload multiple files in a single operation If appropriate, you can merge several PDF files into a single one, using specific software, before uploading A Zip file is recommended only as the container for the literature references; Click “Save and Return” when you have finished uploading documents; At any stage during the procedure above, clicking “Return” on the Submission form page saves the draft submission (which will now appear in your “Draft Submissions” list) You can open it again at a later time to edit/add more information; Click on “Generate Application form” present at bottom of screen next to “Return” button to create a word file for the summary of application filled at that point of time by the applicant Word file will be shown under “Documents from Applicant”; When you are ready to submit your final application, click on “Declaration and re(submission)”: Click on the tick box to the left of the declaration statement (that begins with the words: “I confirm…”) to formally declare that you are authorised to submit the application; Click on the “Declaration and submission” button; If you are unsure or think of any part of the application you want to revise, click “Review Application” and this will return you to the draft submission; If you are sure you want to submit the application, click” Submit” Your application has now been submitted and is locked for edit/upload unless EMA opens it up again for you to add or amend any information or documents You are then returned to the portal “Ongoing Submissions” tab You can now look up the submission you have just submitted using the “Ongoing Submission” The latest submission will appear on top once validation is completed in background, as submissions are sorted by date and time of last update 2.4 Communication only to the Submission Contact (Portal contact) for a submission The communication model for IRIS is that while there can be any number of Industry managers and Industry contributors associated to a single submission, only one of them is the "submission contact", also called the "portal contact" i.e the primary contact person to whom all communication is sent (by default) for a given submission The default "submission contact" is the Industry manager who submits the application The "submission contact" role can be reassigned at any moment, and repeatedly, by any of the Industry managers associated to that submission, but the EMA users of the IRIS system will send communications only to the "submission contact", by default This is for efficiency and security reasons Applicants can nominate additional Industry managers and reassign the "submission contact" role as required, for example before a period of leave of the "submission contact" This can be done in IRIS, by clicking on the V to the right of the submission and selecting "Manage submission contact", as shown in Figure and below In addition, applicants may also wish to set up appropriate auto-forwarding rules in the email system of the "submission contact" IRIS is being built to allow applicants to self-manage their "submission contact" role for each submission In future, EMA plans to extend this concept to self-management of the contact person and contact data for interested parties assigned to Regulatory Entitlement, and potentially also for Authorisation Products Changes will be made by sponsor/marketing authorisation holders directly in the IRIS Industry portal Figure Changing Submission (Portal) Contact From the IRIS home page, carry out the following steps (see also Figure 1): Click on "Draft submissions"/”Ongoing submission” sub-tab present under “Submission” tab; Scroll down and find the application you want from the list of your drafts; On the right hand side, click on the drop-down arrow and select “Manage Submission Contact” (Figure 3); Click “Change submission contact”, then In the pop-up window, select the name of the person you want to add as portal contact and click on “select” (the list shows all managers associated with that submission) New portal contact will be shown in “Portal contact” field Click on “Save and Return” 2.5 Add managers to a draft/ongoing submission You can insert additional managers to a submission also after the creation of submission, but only if the submission is in draft or ongoing status, not if the procedure has been completed You can only this for the draft applications for which you have a “Manager” role (not if you are a Contributor) Managers can edit, submit or withdraw the application From the IRIS home page, carry out the following steps (see also Figure 1): Click on "Draft submissions"/”Ongoing submission” sub-tab present under “Submission” tab; Scroll down and find the application you want from the list of your drafts; On the right hand side, click on the drop-down arrow and select “View/Manage Managers” as Figure 3; Click “Add”, then In the pop-up window, click the magnifying glass search symbol to bring up a list (and find the name you want to add as a contributor; Click “Add” again; To add more maangers to the same application, repeat the steps above 2.6 Add contributors to a draft submission You can only this for the draft applications for which you have a “Manager” role (not if you are a Contributor) Contributors can only edit, but not submit or withdraw the application From the IRIS home page, carry out the following steps (see also Figure 1): Click on "Draft submissions" sub-tab present under “Submission” tab; Scroll down and find the application you want from the list of your drafts; On the right hand side, click on the drop-down arrow and select “View/Manage Contributors”; Click “Add”, then In the pop-up window, click the magnifying glass search symbol to bring up a list (and find the name you want to add as a contributor; Click “Continue to submission form”; To add more contributors to the same application, repeat the steps above 2.7 Delete a draft submission You can only this for the draft applications for which you have a “Manager” role (not if you are a Contributor) Note: you cannot delete a “completed submission”; an “ongoing submission” can be withdrawn, using a similar procedure Click on "Draft submissions" sub-tab present under “Submission” tab; Find the application you want from the list of your drafts; On the right hand side, click on the drop-down arrow and select “Delete Draft” and a confirmation message will open up in a new window (see Figure 1); Click on the "Delete" button to confirm that you want to delete your draft Note: you cannot undo this afterwards, and the draft submission is permanently deleted from IRIS and cannot be restored 2.8 Withdrawal of a Submission You can only this for the Ongoing applications for which you have a “Manager” role (not if you are a Contributor) Note: you cannot withdraw a “completed submission”; Click on "Ongoing submissions" sub-tab present under “Submission” tab; Find the application you want from the list of your drafts; On the right hand side, click on the drop-down arrow and select “Edit/View”, Submission opens in edit Mode Click on ‘Withdraw Submission’ Button present at the bottom as shown in Figure 4.A confirmation window will appear, confirm the withdrawal request Submission status will be in ‘Withdrawal Requested’ as shown in ‘Ongoing Submission’ Tab; Once EMA has processed the request, the submission will move to ‘Completed Submission’ Tab; 10 Figure 34 Documents from Applicant: It is possible to add documents under this tab Select the declaration confirming that documents have been attached and click on “Save and Return” Documents from EMA: This tab is used to check if any documents have been made available by EMA (e.g the Integrated Inspection Report at the end of the process (if applicable) Declare and Submit changes: Once all the above tabs have been filled and the green check marks show, the “Declare and Submit changes” button becomes enabled Click on it and a new screen will open, select the checkbox asking for confirmation that you have read this guidance and the ‘Guidance for applicants/MAHs involved in GMP, GCP and GVP inspections co-ordinated by EMA’ and click on the “Submit Application” button box A pop-up window will appear, giving you a final opportunity to go back and check that all the details have been entered correctly (“Review Application”), or continue and submit Once submitted, the submission will be shown in the “Ongoing Submissions” tab Veterinary Signal Management For specific information on veterinary signal management please consult the document “Guideline on veterinary good pharmacovigilance practices VGVP) Module: Signal Management” on the Pharmacovigilance (veterinary medicines) page of the EMA website and the tutorial documents on the “Union Pharmacovigilance Database: webinar on signal detection and analysis” page of the EMA website 42 8.1 Annual statements submission In addition to the steps in the general procedure as described in Section 2.3 “Create a new submission (general procedure for all submission types)”, select “Annual statements submission” as the submission type Note the following additional points as shown below (Figure 35: Submission Form): Figure 35: Submission Form The reference number will contain VS (e.g EMA/VS/0000001234) for the draft submission Click on “Select Authorised Products” and then click on “Add Products”, select the relevant product(s) (grouping of products will be allowed on the basis of same or similar products), click on “Add” and once the product(s) is(are) added, click on “Save and Return”; Click on “Submission Details”, select the “Period of analysis” (i.e “Date From” and “Date To”) and select the relevant statement on the tab “Benefit-risk balance” (i.e “I confirm that the benefit-risk balance remains unchanged” or “A procedure is ongoing concerning a new risk identified or a change to the benefit-risk profile”) The “Submission Details” step is completed once you click on the tick box next to the statement (that begins with the words: “I confirm ”) and then click on “Save and Return”; Click on “Documents from Applicant”, add all corresponding documents (if applicable) by clicking on “Add files” and then click on “Save and Return”; “Documents from EMA": This tab can be skipped initially, as part of the creation of a new submission process, as no documents are required from the applicant It is used to check if any documents have been made available to you by EMA at a later stage; Click on “Declaration and Submission”, click on the tick box to the left of the declaration statement (that begins with the words: “I confirm…”) to formally declare that you are authorised to submit the application and then click on “Submit Application” to complete the submission of the annual statement 8.2 Signal management submission In addition to the steps in the general procedure as described in Section 2.3 “Create a new submission (general procedure for all submissions type)”, select “Signal management submission” as the submission type and note the following additional points: 43 Click on "Select authorised products” and then click on “Add products” Select the relevant product(s), click on “Add” and then click on "Save and return”; Click on “Submission details”; a Fill in the signal title according to the following format: “Active substance – PRODUCT NAME = VeDDRA term (PT level) in species affected” Please ensure the signal title is specific and does not concern general issues such as potential drug interactions or medication errors In these cases, the consequences of the potential drug interaction or medication errors should be specified (e.g “serious adverse drug reactions including bleeding events following potential drug interaction between X and Y") b Under "Type of signal”, select if it concerns a Signal or an Emerging safety issue (for which a 3-day notification requirement applies) c Under “Date of Analysis”, select the date when the assessment was performed; d Click on “Add VeDDRA”, select the concerned VeDDRA PT term(s) and then click on “Add” e Indicate if any of the VeDDRA terms concerned in the signal is a Medically Important (MI) term Please consult the document “Guideline on veterinary good pharmacovigilance practices (VGVP) Module: Signal Management” for the complete list of MI Terms f Click on “Add Species” and select the concerned animal species, then click “Add” g Under "Previous signal submission” you may link the current signal submission to any previous signal submissions in IRIS E.g., if you previously submitted a signal concerning the same with the proposal to refute the signal, but with the current submission, the conclusion is to propose further regulatory actions such as an SPC update h Under proposal for action, click on “Add” and select the appropriate regulatory action(s), then click on “Add” i Under “Proposal for action description”, please describe the specific proposals for regulatory action(s) indicated above in detail For example: in case of amendment of the product information, you should provide here the specific wording to be amended or added to the SPC and the corresponding section(s) to be updated In case of the signal being proposed to be refuted or for close monitoring, you should provide a brief summary of the review of the cases, including the total number of cases, and the justification for the conclusion of the assessment j Click on "Save and return” Click on “Documents from applicant” Then click on “Add files” and add the corresponding additional documents from the signal assessment In case a thorough assessment is required, such as for signals with proposals for further regulatory action (30-day notification), please add here the filled template used for the signal assessment Then click on “Save and return”; Click on "Declaration and submission”, click on the tick box to the left of the declaration statement (that begins with the words: “I confirm…”) to formally declare that you are authorised to submit the application and then click on “Submit application” to complete the signal management submission 44 Registration of an MAH i-SPOC on supply and availability 8.3 Purpose of this section This section has been developed to show Marketing Authorisation Holders (MAHs) how to use the IRIS platform to establish and maintain an Industry Single Point of Contact (i-SPOC) on supply and availability issues for their portfolio of medicinal products (for human use) authorised in the Union The registration of an MAH i-SPOC takes place in a 2-step approach, as follows: • Step - Set up of an EMA account and role This prerequisite needs to be met to allow a successful registration in the IRIS portal Further instructions are available within Section 9.2 and 9.3 • Step – Create or maintain an MAH i-SPOC in the IRIS portal Information on a successful creation or maintenance of an MAH i-SPOC is further detailed in Section 9.5, 9.6, 9.7 8.4 Preliminary requirement as defined in step EMA Account and appropriate role: for any type of submission in IRIS, • You need an EMA account and, • an appropriate role in IRIS, to login into IRIS IAM registration needs to be done only once; and this will allow you to register an MAH i-SPOC on supply and availability issues as defined in step For information on how to request an EMA account and an appropriate IRIS role (these are two separate actions), please consult the separate IRIS guide to registration and the quick interactive guide to IRIS registration process on the IRIS home page Please be aware of the following timelines when registering an EMA account and role: • User access request to IRIS with a “IRIS Industry User Admin” role can take up to working days; • Registration of a new organisation3 takes up from to 10 working days 8.5 Supported Browsers IRIS can be accessed on any modern Web Browser, including but not limited to Google Chrome (latest version), Internet Explorer 11 and above, Edge (including the new, Chromium-based Edge), Safari 12 and above, Firefox ,Vivaldi Data relating to an organisation such as MAH, sponsors, regulatory authority, manufacturers Includes organisation level data (e.g., organisation name) and location level data (e.g., location address) Each organisation can have one or many locations An active organisation must have at least one active location linked to it 45 8.6 Background Regulation (EU) 2022/123 provides the European Medicines Agency (EMA) with a framework to monitor and mitigate potential and actual shortages of centrally and nationally authorised medicinal products for human use considered critical to address a given 'public health emergency'4 or ‘major event’5 Regulation (EU) 2022/123 article requires that the Agency establish and maintain a list of Industry Single Points of Contact (i-SPOC) of MAHs for all medicinal products authorised in the Union In the event that an authorised product is included in a list of critical medicines identified for a specific public health emergency or major event, this list of contacts will be used to enable rapid, two-way communication between EMA and the MAHs of those identified critical medicines to detect, report, and prevent or manage supply and availability issues Therefore, all MAHs in the Union are required to register an i-SPOC on supply and availability so that EMA can quickly engage with them if their medicines are included in the lists of critical medicines The Agency’s IRIS platform will be used to collect details of i-SPOCs for all MAHs and to facilitate future communication with those MAHs of identified critical medicines during public health emergencies or major events The iSPOCs should oversee the product supply chain, manufacturing capacity management and shortages According to the legislation, MAHs are required to submit the information (i.e i-SPOC details) to the Agency by September 2022 MAHs may wish to set their i-SPOC at company Headquarter level, instead of company affiliate level In this respect, during the registration process the system will allow MAH users to create or maintain a single i-SPOC person for multiple local affiliates (or organisations) For additional instructions on how to select multiple local affiliates and assign a single i-SPOC person to all relevant organisations, please refer to Section 2.4 8.7 Registering an MAH i-SPOC as defined in step Who can register an i-SPOC? In order to register the i-SPOC, user should have already a “MANAGER” role in IRIS Please be informed that only the user with a “MANAGER” role in IAM/IRIS can successfully register an MAH i-SPOC within the IRIS portal Who can be an i-SPOC? MAH staff registered as an i-SPOC must also be affiliated to the organisation in IAM/IRIS The nominated i-SPOC person can, nonetheless, be any MAH user with a “MANAGER” or a “CONTRIBUTOR” role in IAM/IRIS ‘public health emergency’ means a public health emergency recognised by the European Commission in accordance with Decision No 1082/2013/EU ‘major event’ means an event which is likely to pose a serious risk to public health in relation to medicinal products in more than one Member State Such an event concerns a deadly threat or otherwise serious threat to health of biological, chemical, environmental or other origin or incident that can affect the supply, demand or quality, safety, and efficacy of medicinal products Such an event may lead to shortages of medicinal products in more than one Member State and necessitates urgent coordination at Union level in order to ensure a high level of human health protection according to Article 2(b) of Regulation 2022/123 46 Registration process in IRIS portal - workflow The workflow below illustrates the various steps which need to be followed in order to complete a successful registration/maintenance of an MAH i-SPOC within IRIS portal end-to-end A detailed description of the various individual steps is further available below Figure 36 Login into the IRIS Portal with your account credentials and access ‘My Draft Submissions’ present under ‘Submissions’ tab 47 Figure 37 For the registration of an i-SPOC, a new submission should be created Figure 38 Following the standard submission procedure, complete the "1 Choose Applicant Type form" by filling in the mentioned fields: 48 a Select "Organisation" in the "Are you applying as an individual or on behalf of an organisation" & click on "Next" button Figure 39 In the submission type form, select organisation & location ID to which you are affiliated to In the field "Submission Type", click on the search button, select the submission type as "iSPOC" & click on "Select" button Figure 40 System will navigate the user to the next form named "Add Managers & Contributors" For iSPOC registration, no user action is required on this form hence click on NEXT button & proceed to the next screen/form In the next screen, click on button labelled “Add Multiple MAHs” System will display the list of your affiliated organisations 49 Figure 41 Select your organisation for which you want to register an i-SPOC Post selection, click on "Add" button Figure 42 NOTE: Listing of organisations in this screen is dependent on your affiliations in IAM The system will list all the organisations to which you are affiliated with a manager role After the selection of the organisation, system will prompt you to select the i-SPOC All the affiliated users with MANAGER or CONTRIBUTOR role can be selected as an i-SPOC A list is presented/displayed with all affiliated users for selection You can filter/search for i-SPOC user & select an individual record Click on Save & Next button 50 Figure 43 10 User is prompted to fill in the additional information about the contact details of the MAH iSPOC Fields "Job Title", "Department", "Alternative Email" are mandatory in nature Simultaneously, ensure that “Alternative email” address is different than the i-SPOC email address Either “contact number” or “Alternative contact number” information should be provided System will prompt an error message if the mandatory information is not populated Mandatory information is marked with an asterisk (*) Click on the Submit button Figure 44 51 11 System will notify you of the registration outcome (i.e., successful/unsuccessful) by displaying an outcome summary screen message a Valid registration outcome - i-SPOC user should be affiliated in IAM/IRIS with the organisation During the registration process, if the user selects the i-SPOC who is affiliated to the selected organisation; then the registration will be successful & information will be displayed in the section under the green font header b Invalid registration outcome – When the user registers an i-SPOC for multiple organisations at once, then it my happen that selected i-SPOC is not affiliated to all the selected organisations In such case, system will not register the i-SPOC & list the same in the section under the red font header Figure 45 12 Click on "Org Contact" menu option to view the registered i-SPOC contact(s) Figure 46 8.8 Update an MAH i-SPOC For modification of an MAH i-SPOC, user will have to create a new submission & follow the same steps to create an i-SPOC as further defined in section 2.2 52 Who can update an i-SPOC? In order to update/change the i-SPOC, user updating the i-SPOC record, should have a “MANAGER” role in IAM/IRIS Only the user with a “MANAGER” role in IAM/IRIS can register or update an i-SPOC Login into the IRIS Portal with EMA account credentials and access ‘My Draft Submissions’ present under ‘Submissions’ tab For the modification of an i-SPOC, a new submission should be created Following the standard submission procedure, complete the "1 Choose Applicant Type form" by filling in the mentioned fields: Select "Organisation" in the "Are you applying as an individual or on behalf of an organisation" & click on "Next" button a In the submission type form, select organisation & location ID to which you are affiliated to b In the field "Submission Type", click on the search button, select the submission type as "i-SPOC" & click on "Select" button System will navigate the user to the next form named "Add Managers & Contributors" For i-SPOC registration, no user action is required on this form hence click on NEXT button & proceed to the next screen/form In the next screen, click on button labelled “Add Multiple MAHs” Select your organisation for which you want to register an i-SPOC Post selection, click on "Add" button Figure 47 Current i-SPOC details will be displayed on the screen Figure 48 53 After the selection of the organisation(s), system will prompt you to select the i-SPOC All the affiliated users with “MANAGER” or “CONTRIBUTOR” role can be selected as an i-SPOC List displays all the affiliated users for selection You can filter/search for i-SPOC user & select an individual record Click on Save & Next button User is prompted to fill in the additional information about the MAH i-SPOC contact details Fields "Job Title", "Department", "Alternative Email" are mandatory in nature Simultaneously, ensure that “Alternative email” address is different than the i-SPOC email address Either “contact number” or “Alternative contact number” information should be provided System will prompt an error message if the mandatory information is not populated Mandatory information is marked with an asterisk (*) Click on the Submit button 10 System will notify you of the registration outcome (i.e., successful/unsuccessful) by displaying an outcome summary screen Previous record is overridden with the new i-SPOC contact details 11 Click on "Org Contact" menu option to view the registered i-SPOC contact(s) 8.9 Maintain the same i-SPOC for multiple local affiliates MAHs may wish to maintain their i-SPOC at company Headquarter level, instead of an i-SPOC at each individual company affiliate level Hence, during the registration process the system will allow MAH users to create or maintain a single i-SPOC person for multiple, local affiliates (or organisations) Please be aware that in order to have a MAH centralised at Headquarter level the MAH user must be affiliated in IAM/IRIS to multiple local organisations Please follow the standard steps of the i-SPOC registration described in section 2.2 In the “Select organisations” screen, click on button labelled “Add Multiple MAHs” System will allow the user to select one or multiple organisations Figure 49 54 Figure 50 After the selection of the organisation(s), system will prompt you to select the i-SPOC All the affiliated users with “MANAGER” or “CONTRIBUTOR” role can be selected as an i-SPOC List displays all the affiliated users for selection You can filter/search for i-SPOC user & select an individual record Click on Save & Next button Figure 51 Complete the remaining steps System will notify you of the registration outcome (i.e., successful/unsuccessful) by displaying an outcome summary screen Summary screen contains sections: 55 a Valid i-SPOC registration outcome b Invalid i-SPOC registration outcome c If the user selects an i-SPOC who is not affiliated (in IAM/IRIS) to all the selected organisations, then these will marked as erroneous & listed under “Invalid i-SPOC registration outcome” section for re-registration Figure 52 56 ... interactive guide to IRIS registration process on the IRIS home page This guide also contains information on how to request or transfer an RPI (Research Product Identifier) 1.3 Supported Browsers IRIS. .. applications now and in the future For information on how to request an EMA account and an appropriate IRIS role (these are two separate actions), please consult the separate IRIS guide to registration and... Services for Substances, Products, Organisations and Referential Terms Purpose and context 1.1 Purpose of this guide This guide has been produced to show applicants how to use the IRIS platform to